Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

NCT ID: NCT02550899

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-02-28

Brief Summary

A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.

Detailed Description

A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .

Patients with anal incontinence severity Wexner score >7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.

Conditions

Anal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bulkamid injection treatment group 1

Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide

Group Type: ACTIVE_COMPARATOR

Transanal submucosal injection group 1

Intervention Type: PROCEDURE

Transanal submucosal injection using an anoscope using four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide

Bulkamid injection treatment group 2

injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide

Group Type: ACTIVE_COMPARATOR

Transanal submucosal injection group 2

Intervention Type: PROCEDURE

Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide

Bulkamid injection treatment group 3

injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide

Group Type: ACTIVE_COMPARATOR

Transanal submucosal injection group 3

Intervention Type: PROCEDURE

Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide

Interventions

Transanal submucosal injection group 1

Transanal submucosal injection using an anoscope using four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide

Intervention Type: PROCEDURE

Transanal submucosal injection group 2

Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide

Intervention Type: PROCEDURE

Transanal submucosal injection group 3

Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• informed consent, anal incontinence with Wexner score >10

Exclusion Criteria

• ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Daniel Altman

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Altman, MD, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet Danderyd Hospital

Other Identifiers

KIDS

Identifier Type: -

Identifier Source: org_study_id